Germany receives final warning to comply with EU rules on well established medicinal use

The European Commission yesterday took further steps against Germany for incorrectly applying European Union rules on well established medicinal use when authorizing medicinal products pursuant to Directive 2001/83/EC. A reasoned opinion has been sent to the government of Germany, giving it two months to react. If no agreement can be reached, the Commission may refer the case to the European Court of Justice.

EU law foresees a simplified authorization procedure for medicinal products containing an active substance that has been extensively used for at least a decade in the EU and is therefore considered to have a proven track record of safety and efficacy. This procedure allows an applicant to rely on existing scientific literature on the active substance, instead of conducting tests and clinical trials for the product.

Information available to the Commission suggests that, when calculating the period of 10 years, German authorities take less extensive use of the active substance into account, such as clinical trials. This inaccurate calculation of the time period infringes the terms of Directive 2001/83/EC and obscures the clear separation between different authorization procedures, it argues.